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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K061143
Device Name ROBERTSITE STOPCOCK
Applicant
Halkey-Roberts Corp.
11600 M.L. King Blvd.,North
St. Petersburg,  FL  33716
Applicant Contact RADAMES PIERANTONI
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFFREY D RONGERO
Regulation Number880.5440
Classification Product Code
FMG  
Date Received04/25/2006
Decision Date 05/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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